#1: FDA Approves Juluca, First Two-Drug HIV Regimen
Big news has been announced in the realm of HIV, a virus that remains a major global public health issue. Today, the US Food and Drug Administration has OK’ed Juluca—the first complete treatment regimen that contains only two drugs to treat individuals infected with HIV-1, compared with the standard HIV treatment that consists of three or more drugs.
Juluca, a fixed-dose tablet, is comprised of two previously approved drugs: dolutegravir and rilpivirine. It’s approved to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least 6 months, who have no history of treatment failure and no known substitutions associated with resistance to the individual components of the drug.
“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” Debra Birnkrant, MD, director, Division of Antiviral Products in the FDA’s Center for Drug and Evaluation, said in a statement.
The safety and efficacy of Juluca were evaluated in two clinical trials consisting of 1,024 participants who achieved viral suppression via their current anti-HIV medications.
Read more about Juluca here
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